GEA Niro Pharma SD
GEA Niro Pharma SD
GEA Niro Pharma SD
Niro Technologies
For 75 years, Niro has supplied drying plants for powders and particulates
to the pharmaceutical industry. This includes small capacity dryers designed
for R & D as well as industrial size plants for continuous production of
pharmaceutical compounds under cGMP conditions.
Our plant and process expertise is based on Delivering the Right Solutions
experience and R & D. With plants installed around Every Niro plant begins with the customers desire
the world and literally thousands of tests performed, to develop a product that will succeed in the market.
we have established a solid base of expertise In Niro, the customer finds a partner who will assist
related to the needs of the pharmaceutical and him to meet that goal. Our expertise includes primary
biopharmaceutical manufacturing industries. as well as secondary pharmaceuticals, including
technologies for processing Active Pharmaceutical
Ingredients (API) using spray drying, agglomeration,
encapsulation, and spray congealing.
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Niro Pharmaceutical Spray Dryers
4
Design
3. Gas/air disperser
5 4. Cyclone
5. Bag filter
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Customised for Success
Every pharmaceutical plant and system from Niro is
a unique union of proven technology and individual
solutions. Based on standard components, we
supply plants for cGMP production configured to
meet the customers specific requirements. cGMP
requirements to equipment used for spray drying
of API may in some situations be less than those for
final drugs.
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Primary Pharmaceuticals
Active Pharmaceutical Ingredients (API) as well as control of the moisture or residual solvent content
excipients are typically produced by extraction or in the powder, but also enables the creation of
chemical syntheses. In most cases, the material is powders with a tailor-made particle size distribution,
subsequently crystallised, mechanically separated, morphology, and nature.
and dried. These steps can often be replaced by
spray drying. Spray drying does not only offer
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Applications
Secondary Pharmaceuticals
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Standardised Customisation
Todays increased demands for customised design, Atomization and Powder Discharge
special materials of construction, special surface One of the most important choices in a plant
treatment, advanced control systems, GMP configuration is choosing the right atomization
production, and process validation have resulted in and powder discharge method. We offer a wide
continuous improvement in spray dryer design for range of solutions as illustrated.
the pharmaceutical industry.
Atomizer/
Nozzle Options
Atomizer/
Single Point Discharge Nozzle Options
Feed
Inlet air
Main Fines
powder
fraction
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Spray Drying Concepts
Atomizer/
Two Point Discharge Nozzle Options
Inlet air
Feed
Powder Fines
Main
powder
fraction
Atomizer/
Closed Cycle Design Nozzle Options
Feed
HEPA
Drying
Chamber Condenser
Heater
Fan
Solvent
N2 out
N2 in
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Meeting Every Requirement
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PharmaSD
From Niro Pharma Test Station in Copenhagen: GMP suite with a PSD-1 spray dryer in closed cycle mode
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The PharmaSD Series
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Acetone Evaporation Rate at Outlet
Evaporation (kg/h)
300
250 400
200 300
150
200
100
100
50
0 0
Inlet Temperature (C) Inlet Temperature (C)
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PharmaSD
Evaporation (kg/h)
80
150
60
100
40
20 50
0 0
Inlet Temperature (C) Inlet Temperature (C)
1200
1200 1400
1400
1000 1200
1000
800
Evaporation (kg/h)
Evaporation (kg/h)
800
600
600
400
400
200
200
0 0
Inlet Temperature (C) Inlet Temperature (C)
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Plant Components
Single-unit manufacturing combined with the Each module, indeed each system component,
use of standard modules has replaced serial plant must meet the strictest requirements and regulatory
production within the pharmaceutical industry, standards around the world.
enabling truly customised solutions based on
proven systems.
PharmaSD design
options include:
Manufactoring of drying
chamber and cyclone under
strict quality control
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The Complete Partnership
Customer
responsibility User Requirements Performance Qualification
Functional Specification
and Impact Assessment Operational Qualification
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www.geapharmasystems.com
Niro A/S
Gladsaxevej 305
PO Box 45 DK-2860 Soeborg Denmark
Tel: +45 39 54 54 54 Fax: +45 39 54 58 00
GEA Pharma Systems [email protected] www.niro.com